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IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT?S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
? external limb prosthetic devices (use ISO 22523),
? electric wheelchairs (use ISO 7176 (all parts)),
? diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
? personal care ROBOTS (use ISO 13482).
| Author | ISO/TC 299 Robotics |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 1 |
| Number of pages | 144 |
| Weight(kg.) | 0.3448 |
| Year | 2019 |
| Country | Switzerland |